University Responds to Conflict-of-Interest Scandal

Reacting to the widely publicized conflict-of-interest scandal, University of Wisconsin (UW) officials say they are taking steps to resolve the problem at their School of Medicine and Public Health, The Capital Times said.

Dr. Thomas Zdeblick is the UW researcher who received $19 million in payments over five years from Medtronic, Inc., for his help in developing and promoting its spine products, specifically, the Infuse Bone Graft. According to an earlier Wall Street Journal report, payments amounted to far more than he ever disclosed to UW. Also, the Journal noted, UW maintained a policy requiring its researchers to disclose when they receive over $20,000 from a device or drug maker, but no other details are required. The Milwaukee Journal Sentinel reported that over 30 UW physicians exceeded the threshold in 2006 and 2007.

Zdeblick told the Journal he does not receive royalties from any Medtronic products he uses, and has been telling patients about his financial ties to device makers since 1991. According to the Journal, Zdeblick has received royalties for helping to develop Medtronicâ€™s Infuse Bone Graft.

Last year, the Food and Drug Administration (FDA) warned that use of the Infuse Bone Graft and similar devices caused serious problems when used off-label in cervical spine (neck) surgeries; the device is named in several lawsuits that claim Medtronic improperly promoted off-label use, and is the subject of a Justice Department investigation. Medtronic has also been named in three â€œwhistleblowerâ€ lawsuits filed by former employees alleging Medtronic paid doctors to use Infuse Bone Graft and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, but admitted no wrongdoing.

In a joint letter to Senator Charles Grassley (Republican-Iowa), UW System President Kevin Reilly and UW-Madison Chancellor Carolyn Martin said, â€œA task force was established for this purpose, with the goal of identifying, managing, and eliminating conflicts of interest in clinical care,” quoted Capital Times. Earlier this month, UW initiated a month-long pilot program to give patients details about external income earned by doctors and posted signs in seven clinics indicating their doctors might be compensated by drug and device makers, according to the letter, said the Capital Times.

Grassley and Democratic Wisconsin Senator Herb Kohl collaborate on efforts to ensure full disclosure on the financial amounts physicians receive from drug and medical device companies. Last week, the senators introduced the Physician Payments Sunshine Act of 2009, said the Capital Times, which was created to establish a national standard to require drug, device, and biologic makers to report payments to doctors, the paper said, adding that the legislation also requires transactions be documented on a searchable, public database.

Earlier this month the Journal reported that Grassley wrote to Reilly about his concerns with UW-Madison’s reporting requirements and specifically pointed out the Zdeblick issue. In addition to other items, Grassley asked if Zdeblick implanted any of the devices into patients since January of 2006 and how many times such implantations took place. Grassley also requested the disclosure forms provided to such patients that indicate the surgeonâ€™s ties to the device/device maker, said The Capital Times.

The Capital Times reported that Reilly and Martin said Zdeblick implanted 68 Premier Anterior Cervical Plate Systems, 89 Novus LT Cages, five Vantage Anterior Fixation Systems, and 17 Prestige Discs. The two wrote that they were unclear if the senator was looking for a copy of the standard consent form or the individual, signed form. Because of this, said The Capital Times, UW only provided a blank consent form.

A review last week by the Capital Times revealed that UW has no legal right to share in the payouts to Zdeblick since it only requires its researchers to patent inventions through the Wisconsin Alumni Research Foundation (WARF) when funded with federal money.